Class III · Low risk Ongoing
Klarity-C Drops
Reason Subpotent Drug
Cyclosporine 200 mg/mL opthalmic suspension packaged in an amber…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
What was recalled
Cyclosporine 200 mg/mL opthalmic suspension packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Recalling firm
- Martin Avenue Pharmacy, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0073-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Cyclosporine recalls
See all
Class II · Moderate risk Ongoing
Klarity-C
Reason Lack of Assurance of Sterility
Class I · High risk Ongoing
SANDIMMUNE Oral Solution
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk Ongoing
SANDIMMUNE Oral Solution
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class III · Low risk Terminated
Cequa
Reason Subpotent: Out of Specification result observed for low assay
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